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The PATH Study to Promote Physical Activity After Knee Replacement

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ClinicalTrials.gov Identifier: NCT03768206
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Prisma Health-Midlands
Information provided by (Responsible Party):
Christine A Pellegrini, PhD, University of South Carolina

Brief Summary:
The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.

Condition or disease Intervention/treatment Phase
Knee Arthroplasty Behavioral: Standard Physical Therapy Behavioral: Physical therapist discuss aerobic physical activity Behavioral: Physical activity session Not Applicable

Detailed Description:
Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PATH
PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.
Behavioral: Standard Physical Therapy
Participants will receive standard outpatient physical therapy that is typical following knee replacement

Behavioral: Physical therapist discuss aerobic physical activity
Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.

Active Comparator: PATH-12
PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.
Behavioral: Standard Physical Therapy
Participants will receive standard outpatient physical therapy that is typical following knee replacement

Behavioral: Physical activity session
Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.




Primary Outcome Measures :
  1. Number of participants enrolled vs. approached [ Time Frame: Baseline ]
    Feasibility will be determined based on the number of participants enrolled vs. the number approached

  2. Percentage of participants who complete the 12 week assessment [ Time Frame: 12 weeks ]
    Acceptability will be determined by the percentage of participants completing the 12 week assessment.


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: 12 weeks ]
    Total number of minutes of objectively-measured moderate-vigorous intensity physical activity/week



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 40-79 years of age
  • Have had a knee replacement in the last 2 months
  • Be willing to wear and accelerometer for 7 days during assessments
  • Be English speaking

Exclusion Criteria:

  • Have any contraindications to activity
  • Have a mobility limiting comorbidity
  • Have a scheduled surgery within the next 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768206


Contacts
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Contact: Christine Pellegrini, PhD 803-777-0911 cpellegrini@sc.edu

Locations
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United States, South Carolina
Palmetto Health- USC Orthopedic Center Recruiting
Columbia, South Carolina, United States, 29203
Contact: Debbie Brown, MS PT OMT-C    803-296-9207      
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Christine Pellegrini, PhD.    803-777-0911    cpellegrini@sc.edu   
Principal Investigator: Christine Pellegrini, Ph.D.         
Sponsors and Collaborators
University of South Carolina
Prisma Health-Midlands
Investigators
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Principal Investigator: Christine Pellegrini, phD University of South Carolina

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Responsible Party: Christine A Pellegrini, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03768206     History of Changes
Other Study ID Numbers: Pro00081254
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine A Pellegrini, PhD, University of South Carolina:
knee arthroplasty
behavioral intervention
physical activity